Laparoscopic Primary Diaphragm Versus Mesh Repair for Hiatus Hernia: a Long-Term Follow-Up (PRIME LTFU)

• ClinicalTrials.gov Identifier: NCT05662735
• Recruitment Status: Not yet recruiting
• First Posted: December 22, 2022
• Last Update Posted: December 22, 2022
• Sponsor: Rijnstate Hospital
• Collaborator: Rijnstate Vriendenfonds
• Information provided by (Responsible Party): Rijnstate Hospital

Tracking Information

• First Submitted Date: December 7, 2022
• First Posted Date: December 22, 2022
• Last Update Posted Date: December 22, 2022
• Estimated Study Start Date: March 2023
• Estimated Primary Completion Date: June 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 15, 2022)

Percentage of objective recurrence of a hiatal hernia [ Time Frame: 5-10 years ]

Objective measurement of the integrity of the hiatal hernia repair by CT-imaging

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: December 15, 2022)

• Percentage of clinical recurrence of a hiatal hernia [ Time Frame: 5-10 years ]
  Recurrence of symptoms related to a hiatal hernia measured by a questionnaire
• Symptoms of gastroesophageal reflux disease [ Time Frame: 5-10 years ]
  Percentage of participants that develop postoperative gastroesophageal reflux disease, measured by a questionnaire
• Patient satisfaction [ Time Frame: 5-10 years ]
  Overall satisfaction with surgical outcome measured by a questionnaire, on a scale from 0 to 10, where 0 means very unsatisfied with the outcome of the operation and 10 means very satisfied with the outcome of the operation. An additional question will be asked that assesses if the patient would undergo the operation again and can be answered by a simple 'yes' or 'no'.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Laparoscopic Primary Diaphragm Versus Mesh Repair for Hiatus Hernia: a Long-Term Follow-Up
• Official Title: Randomized Controlled Trial of Laparoscopic Primary Diaphragm Repair With Sutures Alone Versus Sutures Reinforced With Mesh for Hiatus Hernia: A Long Term Follow-Up
• Brief Summary: Assessment of the recurrence of hiatal hernia five to ten years after repair using sutures versus sutures reinforced with non-absorbable mesh.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

randomised controlled trial

Masking: Single (Participant)
Masking Description:

Patients were blinded for repair with sutures alone or sutures with mesh augmentation

Primary Purpose: Treatment

Condition

• Hernia, Hiatal
• Laparoscopic
• Surgery
• Recurrence
• Mesh
• Primary

Intervention

• Device: Mesh repair
  Augmentation of hiatal hernia repair with TiMESH® reinforcement
• Procedure: Suture repair
  Primary laparoscopic repair of the hiatal hernia using non-absorbable sutures

Study Arms

• Active Comparator: Non-absorbable sutures
  The hiatal hernia was corrected performing laparoscopic surgery. Primary repair of the hernia was done with non-absorbable sutures
  Intervention: Procedure: Suture repair
• Active Comparator: Non-absorbable sutures and a TiMESH®
  The hiatal hernia was corrected performing laparoscopic surgery. Primary repair of the hernia was done with non-absorbable sutures and a TiMESH® to reinforce the repair.
  Interventions:

  • Device: Mesh repair
  • Procedure: Suture repair

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: December 15, 2022): 60
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 2023
• Estimated Primary Completion Date: June 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Participant of the initial PRIME study
• Alive

Exclusion Criteria:

• No informed consent
• Additional hiatal hernia repair surgery during the follow-up period
• Pregnancy
• Patients that have stated they do not want to be approached for follow-up research

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 16 Years to 100 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Olivier Bouwmeester, MSc; 088 - 005 8888; obouwmeester@rijnstate.nl

• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT05662735
• Other Study ID Numbers: NL82840.100.22
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Rijnstate Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Rijnstate Hospital
• Original Study Sponsor: Same as current
• Collaborators: Rijnstate Vriendenfonds
• Investigators: Not Provided
• PRS Account: Rijnstate Hospital
• Verification Date: December 2022